FDA Drug Recalls

1,739 recalls · Class I, newest first

Class I · High risk Terminated Apr 23, 2019

Titanium 4000, capsule, 4000 mg, 1 count blister card, 30 blister display boxt, distributed by Titanium 4000 UPC 86077000020

Reason Marketed without an approved NDA/ANDA: undeclared sildenafil and tadalafil.

D.B.P. Distribution D-1292-2019

Class I · High risk Terminated Apr 19, 2019

FENTANYL Transdermal System, 12 mcg/h, five (12 mcg/h) systems per carton, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ…

Reason Product Mix-Up: Customer complaint that their carton labeled as Fentanyl Transdermal Systems, 12 mcg/h contained five patches labeled and containing…

Alvogen, Inc NDC 47781-423-47 D-1277-2019

Class I · High risk Terminated Apr 9, 2019

Aphrodisiac Platinum 40000, Proprietary Raw Material 6000 mg, 1 count blister card, 24 cards per box, Distributed by…

Reason Marketed without an approved NDA/ANDA: FDA analysis has found the product to be tainted with sildenafil

Select Distributions LLC D-1344-2019

Class I · High risk Terminated Apr 5, 2019

Kopi Jantan Tradisional Natural Herbs Coffee, 13g individual packages, Manufactured By: Fikrysz (M) Sdn. Bhd., Kedah, Malaysia…

Reason Marketed Without An Approved NDA/ANDA: FDA analysis found this product to be tainted with undeclared sildenafil and tadalafil, two FDA approved drugs…

Brian P. Richardson D-1206-2019

Class I · High risk Terminated Mar 28, 2019

Lidocaine HCl Injection, USP 1 % 50 mg/5 mL (10 mg/mL), 5mL vial, Rx only, Mrd. in India for: AuroMedics Pharna LLC. E Windsor…

Reason Presence of Particulate Matter: One vial was found to contain a hair.

Aurobindo Pharma USA Inc. NDC 55150-162-05 D-1248-2019

Class I · High risk Terminated Mar 15, 2019

8.4% Sodium Bicarbonate Injection, USP 50 mEq (1 mEq/mL) 4.2 grams (84 mg/mL) 50 mL Single-dose fliptop vial, 25 vials per…

Reason Presence of Particulate Matter; glass particulates

Pfizer Inc. NDC 0409-6625-02 D-1073-2019

Class I · High risk Terminated Mar 14, 2019

Blue Fusion Capsules, 1- count blister pack, Distributed by: DNS Distribution 5225 Canyon Crest Dr. Ste 71-640, Riverside, CA…

Reason Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared ingredients: Sildenafil, Tadalafil, desmethyl…

Ata International Inc D-1085-2019

Class I · High risk Terminated Mar 5, 2019

LEOPARD Miracle Honey packaged in a wooden box, UPC 8 699415 910534, containing 12 sachets 180Gr / 6.36 Oz, each 1 Sachet 15 gr /…

Reason Marketed Without An Approved NDA/ANDA: product tainted with undeclared sildenafil, an FDA approved drug for the treatment of male erectile…

USA LESS Inc. D-1135-2019

Class I · High risk Terminated Feb 22, 2019

Golean DETOX capsules, 14 Net: 56 g, 14 packets containing 2 capsules per packet, 28-count capsules per box, MAT XI S.G Co., LTD…

Reason Marketed Without an Approved NDA/ANDA: FDA analysis found product to contain undeclared sibutramine and phenolphthalein. Sibutramine is an appetite…

Golean Detox US D-1009-2019

Class I · High risk Terminated Feb 13, 2019

Maeng Da Kratom, packaged in a) 20 count capsules (UPC 00859667007149), b) 60 count capsules (UPC 00859667007156), c) 150 count…

Reason MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella.

Todd Holiday dba Sunstone Organics D-0989-2019

Class I · High risk Terminated Feb 13, 2019

White Vein Kratom, packaged in a) 20 count capsules (UPC 00859667007347), b) 60 count capsules (UPC 00859667007354), c) 150 count…

Reason MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella.

Todd Holiday dba Sunstone Organics D-0988-2019

Class I · High risk Terminated Feb 13, 2019

White Vein Kratom, packaged in a) 25 gram powder (UPC 00859667007316), b) 50 gram powder (UPC 00859667007323), c) 100 gram powder…

Reason MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella.

Todd Holiday dba Sunstone Organics D-0987-2019

Class I · High risk Terminated Feb 13, 2019

Maeng Da Kratom, packaged in a) 25 gram powder (UPC 00859667007118), b) 50 gram powder (UPC 00859667007125), c) 100 gram powder…

Reason MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella.

Todd Holiday dba Sunstone Organics D-0986-2019

Class I · High risk Terminated Feb 1, 2019

Levoleucovorin Injection, 250 mg/25 mL, (10 mg/mL), 25 mL Single-Use Vial, Rx only, Manufactured for: Mylan Institutional LLC…

Reason Presence of Particulate Matter: particulate matter identified as copper salts

Mylan Institutional Inc D-1059-2019

Class I · High risk Terminated Jan 25, 2019

the silver bullet 10x Capsules, 725 mg each (proprietary blend of: Mucuna Pruriens Extract, Horny Goat Weed, Ginger Root Extract…

Reason Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with undeclared sildenafil and tadalafil

Natures Rx D-0500-2019

Class I · High risk Terminated Jan 8, 2019

5K Premium Enhancement capsule, 5000 mg, 1 count blister card, box of 30, Happy Together Inc., Boynton, FL UPC 649964965644

Reason Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with undeclared sildenafil and tadalafil

Happy Together, Inc. D-0388-2019

Class I · High risk Terminated Jan 3, 2019

Vecuronium Bromide for Injection 20 mg* *1mg/mL when reconstituted to 20 mL Lyophilized, 10 x 20 mg vials, Rx Only, Manufactured…

Reason Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromide for Injection.

Sun Pharmaceutical Industries, Inc. D-0373-2019

Class I · High risk Terminated Jan 3, 2019

Vecuronium Bromide for Injection 10 mg, 1mg/mL when reconstituted to 10 mL Lyophilized, 10 x 10 mg vials, Rx only, Manufactured…

Reason Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromide for Injection.

Sun Pharmaceutical Industries, Inc. NDC 47335-931-40 D-0372-2019

Class I · High risk Terminated Dec 20, 2018

Ceftriaxone for Injection USP, 2 g, packaged in 10 Single Use Vials (NDC 68180-644-01) per box, Rx only, Manufactured for: Lupin…

Reason Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper…

Lupin Pharmaceuticals Inc. NDC 68180-644-01 D-0358-2019

Class I · High risk Terminated Dec 20, 2018

Ceftriaxone for Injection USP, 1 g, packaged in a) one Single Use Vial (NDC 68180-633-01) and b) 10 Single Use Vials per box (NDC…

Reason Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper…

Lupin Pharmaceuticals Inc. NDC 68180-633-01 D-0357-2019

Class I · High risk Terminated Dec 20, 2018

Ceftriaxone for Injection USP, 500 mg, packaged in a) one Single Use Vial (NDC 68180-622-01) and b) 10 Single Use Vials per box…

Reason Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper…

Lupin Pharmaceuticals Inc. NDC 68180-622-01 D-0356-2019

Class I · High risk Terminated Dec 20, 2018

Ceftriaxone for Injection USP, 250 mg, packaged in a) one Single Use Vial (NDC 68180-611-01) and b) 10 Single Use Vials per box…

Reason Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper…

Lupin Pharmaceuticals Inc. NDC 68180-611-01 D-0355-2019

Class I · High risk Terminated Dec 14, 2018

Lubrisine eye drops (polyethylene glycol 400 0.4% and Propylene glycol 0.3%), 30 ML bottle, Manufactured and Distributed by…

Reason Lack of Sterility Assurance and Incorrect/Undeclared excipient: Product was found to contain undeclared colloidal silver

Results RNA, LLC D-0360-2019

Class I · High risk Terminated Dec 11, 2018

Dyural-80 Injection Kit, 1 Dose, Single Use Only, Rx only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC…

Reason Labeling: Not eslewhere classified - The kits include Sodium Chloride, USP, 0.9% which was recalled by the manufacturer due to the product insert…

Asclemed USA Inc. dba Enovachem NDC 76420-0755-01 D-0354-2019

Class I · High risk Terminated Dec 11, 2018

Dyural-40 Injection Kit, 1 Dose, Single Use Only, Rx only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC…

Reason Labeling: Not eslewhere classified - The kits include Sodium Chloride, USP, 0.9% which was recalled by the manufacturer due to the product insert…

Asclemed USA Inc. dba Enovachem NDC 76420-0750-01 D-0353-2019